The FDA has issued an early alert for certain Abbott Diabetes Care sensors over incorrect glucose readings, which have been linked to serious injuries and deaths.
The Dec. 2 alert applies to about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors distributed in the U.S. with model numbers 72081-01, 72080-01, 78768-01 and 78769-01. Abbott reported 736 serious injuries and seven deaths associated with the issue as of Nov. 14. All deaths occurred outside the U.S., according to the alert.
Abbott first notified distributors, providers and patients in a Nov. 24 medical device correction, citing a manufacturing issue that may cause falsely low glucose readings. The company attributed the issue to a single production line and said it has been resolved. About half of the affected devices have likely already been used or expired, according to the company.
Patients have been advised to check sensor serial numbers and stop using any affected models. The alert does not apply to other Libre sensors or readers.
